Women With Breast CancerPhase 3PROPOSENCT06611514
Effect of Intravaginal Prasterone on Symptoms of Genitourinary Syndrome of Menopause (GSM) in Women in Menopause With Previous Breast Cancer
A Phase 3 study testing Prasterone (DHEA) in people with Women With Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial summary
The goal of this interventional study is to evaluate the effect of Intravaginal Prasterone for the treatment of moderate to severe symptoms of genitourinary syndrome (GSM) due to natural, surgical or treatment-induced menopause and the effect on the quality of life, including sexual function and mood well-being, in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Women With Breast Cancer
- What is being tested?
- Prasterone (DHEA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2024to 1 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed breast cancer, completely excised
- Natural or iatrogenic menopausal status
- No evidence of distant metastasis
- Self-identified moderate to severe symptoms of genitourinary syndrome
- Normal kidney and liver function
- Written Informed Consent signed and dated by patient
- Negative Papanicolau (Pap) Smear Cytology Test within 1 year prior to enrollment
Who cannot join
- Vaginal or uterine bleeding of unknown origin
- Current diagnosis of any non-breast malignancy
- Metastatic disease
- Currently on chemiotherapy
- Currently on treatment with tamoxifen
- Mentally incompetent or evidence of active substance or alcohol abuse
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- Endometrial hyperplasia
- Pregnancy or lactation
- Currently use of other vaginal therapy for the same purpose (if present, they have to be stopped 15 days before baseline visit)
- Clinically significant metabolic or endocrine disease not controlled by medication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
European Institute of Oncology
Milan, 20141
SILVIA MARTELLA, 0039 02 943742104, silvia.martella@ieo.it
SILVIA MARTELLA
About this study
Official title: Effect of Intravaginal Prasterone on Genitourinary Syndrome in Women in Menopause With Previous Breast Cancer or Currently Under Treatment With Endocrine Therapy for Breast Cancer With Aromatase Inhibitor +/- LHRHa
The goal of this interventional study is to evaluate the effect of Intravaginal Prasterone for the treatment of moderate to severe symptoms of genitourinary syndrome (GSM) due to natural, surgical or treatment-induced menopause and the effect on the quality of life, including sexual function and mood well-being, in women with Breast Cancer. A sample size of 95 patients will be needed to show that the proportion of women showing symptom improvement is greater than 50%. Subjects will be followed up at four weeks and twelve weeks of treatment. One and three-month outcomes will be provided after the end of treatment. Comparison between menopausal women with previous breast cancer that have finished hormonal therapy or with ER negative breast cancer and women currently under endocrine therapy with AIs will be performed.
- Conditions
- Women With Breast Cancer
- Being tested
- Prasterone (DHEA)
- Keywords
- genitourinary syndrome, prasterone, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prasterone (DHEA)Drug
Prasterone 6.5 mg vaginal tablets
| Study group | Role | What they receive |
|---|---|---|
| intravaginal Prasterone | Experimental | Not described Receives: Drug: Prasterone (DHEA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish subjective improvement in genitourinary symptomatology at intervals marked by the study
To establish the improvement in vulvovaginal and urinary symptoms, by subjective evaluation at baseline, at 12 weeks and after 1 and 3 months after the end of the treatment. Establish tissue trophism improvement through gynecological evaluation, the use of validated scales (Vaginal Health Index), and determination of the maturation index on vaginal spatula, measure serum estradiol during and after treatment
Measured: From enrollment to after 3 months after the end of treatment
evaluation of vulvovaginal and urinary symptoms
evaluation of vaginal dryness, dyspareunia, pruritis, burning and dysuria with a 0 to 4 score (0: absence, 1: mild, 2: moderate, 3: severe, 4: very severe)
Measured: 6 months
improvement in vaginal signs
To establish the improvement in vaginal signs using the Vaginal Health Index Scale (VHI)
Measured: 6 months
evaluation fo maturation index
To assess the maturation index (as percentage of superficial, intermediate and parabasal cells) in the vaginal mucosa
Measured: 6 months
grade of satisfaction
To report the grade of satisfaction as measured by the Global Response Assessment at the end of the study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women With Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SILVIA MARTELLA, Principal investigator, European Institue of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611514
- Sponsor's protocol ID
- UID 2966
- Acronym
- PROPOSE
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravaginal Prasterone on Genitourinary Syndrome in Women in Menopause With Previous Breast Cancer or Currently Under Treatment With Endocrine Therapy for Breast Cancer With Aromatase Inhibitor +/- LHRHa
- ClinicalTrials.gov ID
- NCT06611514
- Acronym / sponsor ID
- PROPOSE / UID 2966
- Conditions
- Women With Breast Cancer
- Keywords
- genitourinary syndrome, prasterone, breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this interventional study is to evaluate the effect of Intravaginal Prasterone for the treatment of moderate to severe symptoms of genitourinary syndrome (GSM) due to natural, surgical or treatment-induced menopause and the effect on the quality of life, including sexual function and mood well-being, in women with Breast Cancer. A sample size of 95 patients will be needed to show that the proportion of women showing symptom improvement is greater than 50%. Subjects will be followed up at four weeks and twelve weeks of treatment. One and three-month outcomes will be provided after the end of treatment. Comparison between menopausal women with previous breast cancer that have finished hormonal therapy or with ER negative breast cancer and women currently under endocrine therapy with AIs will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intravaginal Prasterone | Experimental | Drug: Prasterone (DHEA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed breast cancer, completely excised
- Natural or iatrogenic menopausal status
- No evidence of distant metastasis
- Self-identified moderate to severe symptoms of genitourinary syndrome
- Normal kidney and liver function
Key exclusion criteria (10 listed)
- Vaginal or uterine bleeding of unknown origin
- Current diagnosis of any non-breast malignancy
- Metastatic disease
- Currently on chemiotherapy
- Currently on treatment with tamoxifen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prasterone (DHEA)Prasterone 6.5 mg vaginal tablets | Drug | intravaginal Prasterone |
Primary outcome
Establish subjective improvement in genitourinary symptomatology at intervals marked by the study
Time frame: From enrollment to after 3 months after the end of treatment
To establish the improvement in vulvovaginal and urinary symptoms, by subjective evaluation at baseline, at 12 weeks and after 1 and 3 months after the end of the treatment. Establish tissue trophism improvement through gynecological evaluation, the use of validated scales (Vaginal Health Index), and determination of the maturation index on vaginal spatula, measure serum estradiol during and after treatment
evaluation of vulvovaginal and urinary symptoms
Time frame: 6 months
evaluation of vaginal dryness, dyspareunia, pruritis, burning and dysuria with a 0 to 4 score (0: absence, 1: mild, 2: moderate, 3: severe, 4: very severe)
improvement in vaginal signs
Time frame: 6 months
To establish the improvement in vaginal signs using the Vaginal Health Index Scale (VHI)
evaluation fo maturation index
Time frame: 6 months
To assess the maturation index (as percentage of superficial, intermediate and parabasal cells) in the vaginal mucosa
grade of satisfaction
Time frame: 6 months
To report the grade of satisfaction as measured by the Global Response Assessment at the end of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SILVIA MARTELLA principal investigator
European Institue of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prasterone (DHEA) in people with Women With Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SILVIA MARTELLA (0039 02 943742104, silvia.martella@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish subjective improvement in genitourinary symptomatology at intervals marked by the study (time frame: From enrollment to after 3 months after the end of treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.